SFB540

Dénomination commerciale

non renseigné

00645517380452

00645517AdapterAZ

Numéro de référence/catalogue

SFB540

GS1

Classe I

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

—

URL des informations complémentaires

https://trulife.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• Y062499LOWER EXTREMITY PROSTHESES - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  The use of bolts not supplied by Trulife, or failure to follow instructions, may lead to structural failure of the components subjecting the user to a risk of serious personal injury and will void any warranties offered by Trulife. Do not use the bolt if the threads are nicked or damaged during cutting. The bolt may be cut to avoid any interference. Cut the bolt length as required to engage the full thread length of the mating adapter, or as specified in the adapter install guide, and deburr the cut end to avoid thread damage. Do not install a lockwasher. The foot contains an internal stainless steel washer that does not require a lockwasher. Do not contaminate bolt or bolt clearance in keel with any type of adhesive, glue, or cement. To maintain bolt tightness, apply three drops of Loctite 242/243 to the area of the bolt that will engage the threads of the fitting or nut. Check the bolt periodically for loosening. Looseness in any bolt may lead to failure. A 10 mm bolt is supplied with each adult foot, verify that the correct length of foot bolt is being used. Loctite: When adjusting alignment of bolts or screws that have been assembled with Loctite, the threads of the screw and screw hole should be cleaned free of any Loctite residue with a mild solvent such as alcohol. Then reapply new Loctite to ensure the proper torque value of the fasteners are set when retightened.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.